The Immunoassay Linearity Set is intended to simulate human patient serum samples for the purpose of verifying and validating the Analytical Measurement Range for non-waived immunoassay testing methods as identified in the package insert.
Device Story
Audit™ MicroCV™ Immunoassay Linearity Set is a lyophilized, five-level quality control material containing 17 analytes in a human and bovine serum albumin matrix. Levels A-E are prepared via linear dilution to span the reportable range of clinical analyzers. Used in clinical laboratories for proficiency testing, CLIA-directed calibration verification, and as assayed/unassayed quality control material. The healthcare provider reconstitutes the material and runs it on specified analyzer systems; results are compared against target values to verify instrument linearity and performance. Benefits include ensuring accurate measurement of immunoassay analytes and compliance with CLIA-88 regulatory requirements.
Clinical Evidence
No clinical data. Bench testing only. Stability studies confirmed reconstituted stability of 5 days at 2-8°C and a shelf life of two years when stored unopened at 2-8°C.
Technological Characteristics
Lyophilized, five-level set; human and bovine serum albumin matrix; contains 17 analytes and preservatives. Levels A-E are equidistant concentrations. Storage at 2-8°C. Reconstituted stability: 5 days at 2-8°C. Intended for use as assayed QC material only for specific instruments listed in package insert.
Indications for Use
Indicated for use as a quality control material to verify and validate the Analytical Measurement Range for non-waived immunoassay testing methods, including Cortisol, Digoxin, Estradiol, Ferritin, Folate, Free T4, FSH, hCG, LH, Progesterone, Prolactin, Testosterone, Total PSA, Total T3, Total T4, TSH, and Vitamin B12. Used for proficiency testing and CLIA-directed calibration verification. Can serve as unassayed QC or assayed QC for specified analyzer systems.
Regulatory Classification
Identification
A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.
Predicate Devices
Audit™ MicroCV™ General Chemistry Linearity Set (k042318)
Submission Summary (Full Text)
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510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION
DECISION SUMMARY
ASSAY ONLY TEMPLATE
A. 510(k) Number:
k062668
B. Purpose for Submission:
New device
C. Measurand:
Quality control set for Cortisol, Digoxin, Estradiol, Ferritin, Folate, Free T4, FSH, hCG, LH, Progesterone, Prolactin, Testosterone, Total PSA, Total T3, Total T4, TSH, and Vitamin B12.
D. Type of Test:
Quality control material
E. Applicant:
Aalto Scientific, Ltd.
F. Proprietary and Established Names:
Audit™ MicroCV™ Immunoassay Linearity Set
G. Regulatory Information:
1. Regulation section:
21CFR 862.1660, Quality control material (assayed and unassayed).
2. Classification:
Class I, reserved
3. Product code:
JJY, multi-analyte controls, all kinds (assayed and unassayed)
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4. Panel:
Clinical Chemistry (75)
H. Intended Use:
1. Intended use(s):
See indications for use below.
2. Indication(s) for use:
The Audit™ MicroCV™ Immunosassay Linearity Set consists of five levels in Human and Bovine serum albumin matrix. Each level contains the following analytes: cortisol, digoxin, estradiol, ferritin, folate, free T4, FSH, hCG, LH, progesterone, prolactin, testosterone, total PSA, total T3, total T4, TSH, and vitamin B12. The five levels demonstrate a linear relationship to each other for their respective analytes, reagents, and instruments.
This product may be used for proficiency testing in interlaboratory surveys and to perform CLIA directed calibration verification for these same analytes with similar reagents on similar instrumentation in accordance with current CLIA-88 guidelines and regulations.
In addition, level A-E of this product may be used as unassayed quality control material for these analytes or as an assayed quality control material for the analyzer systems specified in the package insert. It is not intended to be used as an assayed quality control material for any other analyzer systems.
3. Special conditions for use statement(s):
For prescription use only.
4. Special instrument requirements:
This device may be used as an assayed quality control material only for the instrument system specified in the package insert.
I. Device Description:
The Audit MicroCV Immunoassay Linearity Set is a human and bovine serum albumin based, lyophilized, five level set of QC material, with each level containing 17 analytes and a preservative. Level A is near the lower limit of instruments and Level E is near the upper limit of instruments. Levels B-D are related by linear dilution of Level A and Level E.
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J. Substantial Equivalence Information:
1. Predicate device name(s):
Audit™ MicroCV™ General Chemistry Linearity Set
2. Predicate 510(k) number(s):
k042318
3. Comparison with predicate:
| Similarities | | |
| --- | --- | --- |
| Item | Device: Audit MicroCV Immunoassay Linearity Set | Predicate: Audit MicroCV General Chemistry Linearity Set |
| Intended use | Linearity Material or Assayed QC Material (for analyzer specified in package insert only) | Linearity Material or Assayed QC Material (for analyzer specified in package insert only) |
| Number of Levels per set | 5 | 5 |
| Contents | 5 x 5 ml | 5 x 5 ml |
| Form | Lyophilized | Lyophilized |
| Preservative | Yes | Yes |
| Storage | 2 to 8°C | 2 to 8°C |
| Differences | | |
| --- | --- | --- |
| Item | Device: Audit MicroCV Immunoassay Linearity Set | Predicate: Audit MicroCV General Chemistry Linearity Set |
| Number of Analytes per Vial | 17 | 30 |
| Matrix | Human and bovine Serum Albumin based | Human Based Serum |
| Analytes | Cortisol, Digoxin, Estradiol, Ferritin, Folate, Free T4, FSH, hCG, LH, Progesterone, Prolactin, Testosterone, Total PSA, Total T3, Total T4, TSH, and Vitamin B12 | Acid Phosphatase, Albumin, Alkaline Phosphatase, ALT, Amylase, AST, Bilirubin (Total and Direct), BUN, Calcium, Chloride, Cholesterol, CO2, Creatine Kinase, Creatinine, Gamma-GT, Glucose, HDL Cholesterol, Iron, LDH, LDL Cholesterol, Lactate, |
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| Differences | | |
| --- | --- | --- |
| Item | Device: Audit MicroCV Immunoassay Linearity Set | Predicate: Audit MicroCV General Chemistry Linearity Set |
| | | Lipase, Magnesium, Phosphorus, Potassium, Sodium, Total Protein, Triglycerides and Uric Acid |
| Reconstituted Stability | 5 days at 2 to 8°C | 7 days at 2 to 8°C except for enzymes and bilirubin which are 48 hours |
## K. Standard/Guidance Document Referenced (if applicable):
Not Applicable
## L. Test Principle:
Not Applicable
## M. Performance Characteristics (if/when applicable):
1. Analytical performance:
a. Precision/Reproducibility:
Not Applicable
b. Linearity/assay reportable range:
The Audit™ MicroCV™ Immunoassay Linearity Set is prepared such that the analyte concentrations are equidistant across levels A – E, with Level A containing the lowest concentrations and Level E the highest concentrations. A linearity study was performed for each analyte by measuring all five levels and calculating an R² value and comparing the measured value of each control level to the target value assigned to each level during the value assignment process (see Value Assignment below). The R² value and the measured vs. target values met the sponsor’s acceptance criteria for each analyte.
c. Traceability, Stability, Expected values (controls, calibrators, or methods):
Traceability
The base matrix consists of human serum albumin, bovine serum albumin, and preservatives. The analytes are derived from both human and non-human sources and were obtained from commercial vendors. The low and high level analytes were adjusted to within the desired target range of each assay. The remaining 3 points are dilutions of the low and high levels.
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# Shelf Life Stability
The sponsor’s unopened bottle shelf life stability claim is two years from the date of manufacture. All analytes were placed on heat stress stability in closed bottles at 37°C and tested on day 0 and day 20. The sponsor supplied a Heat Stress Stability Prediction chart that allowed an analyte heat stressed for 17.5 days at 37°C to predict two year stability at 2-8°C. After 20 days at 37°C all analytes met the manufacturer’s acceptance criteria for deviation from day 0. Real time stability studies are on going to support the accelerated studies.
# Reconstituted Stability
The sponsor claims the reconstituted control is stable for 5 days when stored tightly capped at 2-8°C. All analytes were reconstituted on day 0 and stored in tightly capped bottles at 2-8°C for five days. All analytes were tested on day 0 and day 5 and met the manufacturer’s acceptance criteria for deviation from day 0.
# Value Assignment
Each analyte was measured multiple times and the mean value of each analyte was used to establish target values at each level. The target ranges were calculated as ±20% of the target value. These values are only applicable for the instrument specified for each analyte in the Instructions for Use.
d. Detection limit:
Not Applicable
e. Analytical specificity:
Not Applicable
f. Assay cut-off:
Not Applicable
2. Comparison studies:
a. Method comparison with predicate device:
Not Applicable
b. Matrix comparison:
Not Applicable
3. Clinical studies:
a. Clinical Sensitivity:
Not Applicable
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b. Clinical specificity:
Not Applicable
c. Other clinical supportive data (when a. and b. are not applicable):
Not Applicable
4. Clinical cut-off:
Not Applicable
5. Expected values/Reference range:
Not Applicable
N. Proposed Labeling:
The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.
O. Conclusion:
The submitted information in this premarket notification is complete and supports a substantial equivalence decision.
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Learn the FDA Browser
Two short videos show you everything — or skip straight to the written tutorial if you'd rather read. You can reopen this any time from the Tutorial button in the top bar.
Part 1 — Search, results, and everyday workflows 16 min
Part 2 — Embeddings: the galaxy map 3 min
1. Search: exact and fuzzy
Type a phrase like "coronary artery calcification" into the search box. You get two kinds of results. Exact results match the literal phrase — prefix searches work ("coronary artery calcificati") but suffix searches do not. Fuzzy results match on the meaning and intent of your phrase rather than the exact words, and are sorted by relevance score. Hover over the Exact or Fuzzy badge on any row to see exactly why it matched.
Use the checkboxes above the results to narrow: SaMD keeps only software-only devices, AI / ML keeps only devices with AI.
Exact vs. fuzzy search: what's the difference?
Exact matches on the literal phrase (prefix search works, suffix does not). Fuzzy matches on the meaning and intent of the phrase rather than the exact words. Hover over the badge on any row to see why it matched.
You search "coronary artery calcification" and want only software devices with AI. What two filters do you apply?
Narrow by SaMD (software-only devices), then narrow by AI/ML (devices with AI).
2. The results table
Scroll right in the results table. The intended use is extracted for you — no need to open the PDF. The device story gives a high-level snapshot of what the device does and how it's used. The AI Performance sub-table shows each output name, acceptance criteria, observed values, and development/test dataset descriptions — the same format Innolitics uses for regulatory strategy outputs, and the fastest high-level fingerprint of an AI device. It is AI-generated but has been very reliable in practice.
Where do you find a device's intended use without opening the PDF?
Scroll right in the search results table. The intended use column is extracted for you; no need to dig into the 510(k) summary PDF.
What does the AI Performance sub-table show, and why is it useful?
Output name, acceptance criteria, observed values, development dataset description, and test dataset description. It's the same format we use for regulatory strategy output and Fast 510(k) input, and the fastest high-level fingerprint of an AI device. AI-generated but reliable in practice.
3. Judging fuzzy relevance
Fuzzy results trail off in relevance as you scroll. Use three signals to decide how far down to go: the fuzzy badge explanations, the intended use column, and whether your target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, you're past the relevant zone. A top hit with a low score (~0.4) and a stretched explanation is a hint the closest predicates are far away — the project may be headed for De Novo. Note the fuzzy search is a pattern match: it doesn't handle negation ("not") well, and hardware devices can appear — filter by SaMD/AI ML to cut them.
How do you judge how far down fuzzy search results to go?
Use the relevancy signals: the fuzzy badge explanations, the intended use column, and whether the target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, results are trailing off in relevancy.
4. Device detail page: chat and citations
Click a device name to open its detail page: device facts on the left, a chat window on the right. Ask something like "Describe the training data". The answer carries little citation bubbles — click one to jump to the highlighted passage in the source PDF, so you can verify every AI answer against the document. There's also a Download PDF button for sharing.
How do you verify an AI chat answer on the device detail page?
Click the citation bubbles to jump to the relevant highlight in the source document.
Reading rule for every project: how many summaries do you read in full?
At least the three most relevant 510(k) or De Novo summaries, in full. After that, use targeted chat questions to confirm your memory quickly. The tool supports this professional habit — it doesn't replace it.
5. Side-by-side comparison
Select multiple rows in the results table (aim for under ~10), then open the PDF Viewer tab. Ask one question — it goes to all selected devices in parallel, each with citations. This is the fastest way to compare and contrast devices: training data, PCCP scope, how they handled adding new scanners, and so on.
What does the side-by-side PDF viewer mode do?
Select multiple devices, open the PDF viewer tab, and ask one question (e.g., "Describe the training data"). It queries all selected devices simultaneously with citations, so you can compare and contrast quickly.
6. Collections
With rows selected, go to the Collections tab and create a labeled collection (e.g., "Cobb Angle Project"). Reload that selection any time — before a client call, pull up the collection and ask questions across all of its devices at once.
How do you save a set of selected devices for later use?
Select the rows, go to the Collections tab, and create a labeled collection (e.g., "Cobb Angle Project"). You can reload the selection anytime and carry it into the PDF viewer and other tabs that support selections.
7. Product codes and the regulations tree
Click a product code in the results to jump to it in the regulations tree — identification text, sibling product codes, and devices you can open in a PDF viewer on the right. Click a regulation number to see its identification, special controls, and related product codes. You can also search by product code or regulation number at the top of the tree. Always read the special controls if any exist for your device — it broadens your search and sharpens pre-kickoff research.
What can you do from the regulations tree view?
Browse product codes and regulation numbers, read the identification text and special controls, browse sibling product codes, open device PDFs on the right, and search by product code or regulation number at the top of the tree.
8. Chart view
Click Show Chart and segment by regulation number (or product code) to see which regulations dominate your result set. Clicking a regulation takes you into the regulations tree. Great for spotting that most matches are, say, hardware laparoscopic devices — a cue to go back and filter.
How do you see which regulations dominate a search result set?
Click "Show Chart" and segment by Regulation Number. Clicking a regulation takes you to the regulations tree.
9. The predicate graph
Open the Predicates tab for a family-tree view of predicate relationships. Click a node to trace its parents and children; selections from search carry over pre-selected. Commonly predicated devices are worth reading — a lot of people predicated them for a reason. The visual lineage is also handy on client calls, e.g. to show how a predicate family evolved and justify why your predicate still holds.
In the predicate graph, why are commonly predicated devices worth reading?
A lot of people predicated them for a reason. Clicking a node traces parents and children, and selections from search carry over pre-selected.
10. Embeddings: the galaxy map
The Embeddings tab plots every matching document in a 2-D "galaxy map" where semantically similar devices cluster together. Hover or click clusters to explore, and let AI label the clusters for you. Embeddings beat product codes for grouping: two devices can carry different product codes (LLZ vs. QIH) yet do the same thing — the embedding captures the meaning of the intended use and device story. This is also exactly how retrieval-augmented generation (RAG) works under the hood, and it makes a great visual on client calls.
Try it yourself
Head to the search page and work through a few of these AI/ML fuzzy searches to build intuition: perivascular fat on CT · aortic valve calcification opportunistic screening on noncontrast CT · breast cancer prediction on digital pathology slides · autism detection · gestational age prediction · a hearing aid that can also detect a pulse · foundation model based analysis of ECG · large language models · penetration test. Watch how the relevance scores, intended use, and AI Performance tables tell you when results stop being meaningful.
